Biomarker Database Generation and Use

Abstract

Databases methods and reagents are disclosed for the generation of large amounts of biomarker data from readily obtained sample such as dried plasma spots, and for uses of such databases in the development of patient categorization or detection of changes in a patient's health status over time.

1 . A method of biomarker database generation comprising identifying a biomarker set to include in a database; obtaining reference biomarker molecules that comprise biomarker components that differ in mass spectrometric migration from the protein biomarkers; obtaining at least one sample to assay for inclusion into the database; providing the reference protein biomarker molecules to the sample; subjecting the sample to mass spectrometric analysis to generate a mass spectrometric analysis output; identifying the reference biomarker molecules in the mass spectrometric analysis output; and scoring mass spectrometric spots predictably offset from the reference protein biomarker molecules as spots indicative of reference protein biomarker molecules. 
     
     
         2 . The method of  claim 1 , wherein the reference biomarker molecules are chemically modified. 
     
     
         3 . The method of  claim 1 , wherein the reference biomarker molecules are at least one of oxidized, acetylated, methylated, and phosphorylated. 
     
     
         4 . The method of  claim 1 , wherein the at least one sample comprises a dried plasma sample. 
     
     
         5 . The method of  claim 1 , wherein the at least one sample comprises a collected breath sample. 
     
     
         6 . A processor comprising a memory unit configured to store data indicative of health status categorization in a comparison sample, said memory unit comprising: storage capacity configured to receive reference mass spectrometry data for at least 20 mass spectrometric values derived from each of a plurality of analyzed dried samples; storage capacity to correlate said at least 20 mass spectrometric signals derived from each of a plurality of analyzed dried blood samples to non-mass spectrometry data comprising at least one of age of sample source individual, time of collection, geographical region of collection, demographic information, blood glucose levels at time of collection, sleep history at time of collection, and mental alertness at time of collection; a comparison unit configured to receive at least one individual dataset comprising mass spectrometry data for at least 50 mass spectrometric signals derived from each of a plurality of analyzed dried blood samples and non-mass spectrometry data comprising at least one of age of sample source individual, time of collection, geographical region of collection, demographic information, blood glucose levels at time of collection, sleep history at time of collection, and mental alertness at time of collection; and compare said individual dataset to said reference mass spectrometry data, such that an assessment as to whether the individual data set differs significantly from the reference dataset is made. 
     
     
         7 . A method of biomarker data accumulation comprising obtaining a dried fluid sample from at least one subject, volatilizing the dried fluid sample, subjecting the sample to mass spectrometric analysis, and identifying at least 20 biomarkers in the mass spectrometric analysis.